Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

June 5, 2012

J&J Ethicon Will Stop Sales of Trans Vaginal Mesh

According to Johnson & Johnson (JNJ)’s Ethicon unit, the company has announced in a letter this week that it intends to stop selling four vaginal mesh implants. The letter was sent to the court overseeing the Vaginal Mesh lawsuits.

Johnson & Johnson said it has requested approval from the Food and Drug Administration to stop “commercializing” the devicesFDA Warnings

According to the FDA, J&J had sold one of the implants, the Gynecare Prolift, for three years without proper regulatory approval.

The regulatory agency issued an order in January that J&J and 30 other makers of vaginal mesh implants study organ damage and other health complications blamed on the products, which are used to treat female stress urinary incontinence and pelvic organ prolapse.

The affected products includes the Prolift, Prolift+ M, TVT Secur and Prosima surgical meshes. Ethicon said it’s asked the agency to let it continue selling a fifth product, the Gynecare Gynemesh, with a change to the labeling that restricts its use.

Thousands of Lawsuits expected

According to the hundreds of lawsuits filed, the meshes are pushed into place through incisions in the vagina, and have eroded and shrank over time, causing pain and injuries. Experts believe that since trans vaginal mesh surgery is commonly used procedure for stress incontinence and pelvic prolapse , the number of lawsuits is only expected to increase with time.

Patients have filed suits against J&J, C.R. Bard Inc. and Endo Health Solutions Inc., along with other manufacturers.

FDA Reports

The FDA report last year found a fivefold increase in deaths, injuries or malfunctions related to vaginal mesh for pelvic organ prolapse. Later, an advisory panel urged the FDA to reclassify the devices as “high-risk” products needing human testing.

Ethicon introduced its Gynecare Prolift mesh in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened muscles. The FDA said it learned of the Prolift only in 2007, when J&J sought approval for a related product.

The company said it could market the Prolift without approval because it was so similar to the already approved Gynecare Gynemesh. The FDA cleared the Prolift in May 2008.

The case is In Re Ethicon Inc. Pelvic Repair System Product Liability Litigation, MDL No. 2327, U.S. District Court for the Southern District of West Virginia (Charleston).

If you are a legal copyright holder or a designated agent for such and you believe a post on this website falls outside the boundaries of "Fair Use" and legitimately infringes on yours or your clients copyright we may be contacted concerning copyright matters at the addresses above.

In accordance with section 512 of the U.S. Copyright Act our contact information has been registered with the United States Copyright Office. "Safe Harbor" noticing procedures as outlined in the DMCA apply to this website concerning all 3rd party posts published herein. If notice is given of an alleged copyright violation we will act expeditiously to remove or disable access to the material(s) in question. It is our strict policy to disable access to accounts of repeat copyright violators. All 3rd party material posted on this website is copyright the respective owners/authors. DallasFortWorthInjuryLawyer.com / ShezadMalik.com makes no claim of copyright on such material.